DYONICS 7205357Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03596010251800), received between Oct 25, 2017 and Apr 27, 2021 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MINI MOTOR DRIVE UNIT EP-1 IS NOT WORKING PROPERLY. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A BLADE STALL WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731479 ↗
• MalfunctionFeb 17, 2021Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT CONNECTOR WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A JAMMED MOTOR/BLADE STALL ERROR WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337944 ↗
• MalfunctionFeb 17, 2021Mechanical Jam

  IT WAS REPORTED THAT THE CONNECTOR OF THE MOTOR DRIVE UNIT HAD A PROBLEM. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD AN INTERMITTENT BLADE STALL ERROR WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11337806 ↗
• MalfunctionDec 16, 2020Mechanical Jam; Protective Measures Problem; Mechanical Jam; Protective Measures Problem

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT HAD AN ERROR CODE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE HAD A JAMMED MOTOR/BLADE STALL ERROR AND THIS IS A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016756 ↗
• MalfunctionNov 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MINI MOTOR DRIVE UNIT STALLED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10835586 ↗
• MalfunctionNov 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MINI MOTOR DRIVE UNIT STALLED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10835567 ↗
• MalfunctionNov 2, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WOULD NOT WORK AT ALL DURING PROCEDURE. NOT OSCILLATION OR FORWARD/REVERSE FUNCTIONED. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10775360 ↗
• MalfunctionOct 13, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR DRIVE UNIT WAS NOT TURNING ON. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; NO COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD A JAMMED MOTOR/ BLADE STALL WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10669625 ↗
• MalfunctionSep 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MINI MOTOR DRIVE UNIT STALLED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10599731 ↗
• MalfunctionSep 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MINI MOTOR DRIVE UNIT STALLED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10599672 ↗
• MalfunctionSep 29, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE MINI MOTOR DRIVE UNIT STALLED. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10599617 ↗
• MalfunctionMay 7, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SHIVER RAZOR COULD NOT BE USED FOR TISSUE JOINT REMOVAL SINCE IT THE MOTOR IN THE HAND PIECE FAILED AS IT WAS INDICATED IN THE CONSOLE. PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO SIGNIFICANT DELAY WAS REPORTED AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8588399 ↗
• MalfunctionApr 16, 2019Circuit Failure

  IT WAS REPORTED A SHORT CIRCUIT ON THE DEVICE. NO PATIENT INVOLVED AS THE FAILURE WAS FOUND BEFORE THE SURGERY. THERE WERE NO OVERHEATING, SPARKING , ERROR MESSAGE OR SMOKE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8520551 ↗
• MalfunctionApr 5, 2019Positioning Problem; Temperature Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING ANKLE ARTHROSCOPY, THE HANDPIECE WAS HEATING, IT WAS NOTICED THAT THE INNER BLADE DID NOT ROTATE. ANOTHER CONSOLE WAS USED BUT THE ISSUE STILL REMAINED. THE CONSOLE WAS RESET AND THE PORT WAS CHANGED BUT THE HANDPIECE DID NOT WORK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CONSIDERABLE DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8487835 ↗
• MalfunctionJan 30, 2019Mechanical Problem; Overheating of Device

  IT WAS REPORTED THAT THE HANDPIECE MOTOR WOULD NOT RUN AND, AS A CONSEQUENCE, OVERHEATED. AS THE ALLEGED MALFUNCTION HAPPENED BEFORE ANY CASE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8291434 ↗
• MalfunctionJan 8, 2019Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE WAS BROKEN. NO BACK UP DEVICE WAS AVAILABLE. THERE WAS NO DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8229929 ↗
• MalfunctionJan 8, 2019Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DEVICE WAS SHORT CIRCUITING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. UNKNOWN IF THERE WAS A DELAY, IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8229927 ↗
• MalfunctionJan 4, 2019Electrical Shorting

  IT WAS REPORTED THAT THE DEVICE WAS SHORT CIRCUITING. IT IS UNKNOWN IF THE EVENT HAPPENED DURING A PROCEDURE AND IF THERE WAS A DELAY OR BACKUP AVAILABLE.

  Patient problems: No Information

  MAUDE report 8219491 ↗
• MalfunctionOct 25, 2017Device Inoperable; Device Displays Incorrect Message; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE HAND PIECE OF THE MINI MOTOR DID NOT WORK DURING THE SURGERY. THE PEDAL WAS ACTIVATED AND THE CONSOLE LOOKED AS IF IT WAS WORKING BUT THE BLADE DID NOT MOVE, THE PEDAL WAS CHANGED, THE BLADE WAS CHANGED, BUT IT DID NOT WORK. AFTER TRYING SEVERAL TIMES AND DISCONNECTING AND RECONNECTING THE CONSOLE, IT STARTED TO WHISTLE AND AN ENGINE ERROR SIGN CAME OUT. DOCTOR THEN DECIDED TO PERFORM AN OPEN SURGERY TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976526 ↗